NCT05618886 The Effect of Pelvic Floor Muscle Training for Urinary Incontinence in Nepalese Women
| NCT ID | NCT05618886 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Kathmandu University School of Medical Sciences |
| Condition | Urinary Incontinence |
| Study Type | INTERVENTIONAL |
| Enrollment | 136 participants |
| Start Date | 2023-06-15 |
| Primary Completion | 2025-06-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 136 participants in total. It began in 2023-06-15 with a primary completion date of 2025-06-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of the study is to find the effectiveness of Pelvic floor muscle training (PFMT) for urinary incontinence (UI) among Nepalese women. After screening the women who meet the inclusion criteria will be included. Verbal and written consent will be taken from individual participants then the baseline questionnaire data containing socio-demographic variables and questions related to knowledge of UI, PFM and experience with PFMT and ICIQ UI SF will be collected. Then, a women's health physiotherapist will provide education about UI, PFM, PFMT and lifestyle advice. After the education session the randomisation of the participants into either education only (group A) or education plus PFMT (group B) 1:1 by concealed allocation (sealed envelope with A and B). After allocation, the participants will stay in their assigned intervention group for 1 year. After 12 weeks of the supervised intervention again ICIQ UI SF will be administered by a research assistant to both groups. In the 6th month again ICIQ UI SF will be administered by a research assistant to both groups. Finally, in the 12th month again ICIQ UI SF along with self-efficacy and knowledge questions will be assessed to find the effectiveness of the intervention. This data will help in the further development of the protocol or guideline for the Nepalese women.
Eligibility Criteria
Inclusion Criteria: * Between age of 18-45 years * ICIQ grading above 3 * Understand Nepali language * Willing to be included in the study * Phone availability Exclusion Criteria: * Pregnant * Planning for pregnancy within a 6 months period * Waiting for gynaecological surgery * History of bladder, renal, or uterine cancer * Menopause * Stage IV pelvic organ prolapse * Cognitive or mental disorders * Illness to mother or family members, not making exercising possible
Contact & Investigator
Ranjeeta Acharya, PhD
PRINCIPAL INVESTIGATOR
KUSMS
Frequently Asked Questions
Who can join the NCT05618886 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 45 Years, studying Urinary Incontinence. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05618886 currently recruiting?
Yes, NCT05618886 is actively recruiting participants. Contact the research team at bimikakhadgi@kusms.edu.np for enrollment information.
Where is the NCT05618886 trial being conducted?
This trial is being conducted at Dhulikhel, Nepal, Kathmandu, Nepal.
Who is sponsoring the NCT05618886 clinical trial?
NCT05618886 is sponsored by Kathmandu University School of Medical Sciences. The principal investigator is Ranjeeta Acharya, PhD at KUSMS. The trial plans to enroll 136 participants.